Abramson Cancer Center at Penn Medicine
The research study is being conducted to study whether performing injections of a new treatment, called RP2, directly into stomach and esophagus tumors along with standard chemotherapy (called FLOT) is safe and whether it does a better job of killing cancer before surgery compared to chemotherapy alone.
This is a single-arm, phase II study using a Simon two-stage optimal design with a 6 patient safety run-in evaluating the addition of intra-tumoral injections of RP2 to standard of care perioperative FLOT for patients with stage II or higher, non-metastatic esophageal, gastroesophageal junction (GEJ), or gastric adenocarcinoma. We hypothesize that the addition of RP2 to perioperative FLOT will be safe and will significantly improve pathologic complete response (pCR) rate compared to the historical weighted average of 12% observed with perioperative FLOT in the ESOPEC trial, MATTERHORN trial, a…
Inclusion Criteria: * Patients must have histologically confirmed and clinically staged T2 or higher or node positive, non-metastatic esophageal, gastroesophageal junction, or gastric adenocarcinoma. * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. * Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform the appropriate surgical procedure based on patient's primary tumor site. * Patients must have normal organ and bone marrow function, as defined below, less than or equal to 1…
Upper endoscopy with RP2 intra-tumoral injection of 1 x 10(6) plaque forming units (PFU)/mL for first intra-tumoral injection, up to 10mL of 1x107 PFU/mL of RP2 for subsequent intra-tumoral injections. Injection will occur within 4 days prior of each cycle FLOT.
5-Fluorouracil as part of the FLOT regimen 2,600mg/m2 intravenous infusion over 24 hours on day 1 of each 14-day cycle for 4 cycles.
Leucovorin as part of the FLOT regimen 200mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.
Oxaliplatin as part of the FLOT regimen 85mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.
Docetaxel as part of the FLOT regimen 50mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.
Pegfilgrastim or Filgrastim is required on the study and should be administered per the package insert of the commercially obtained drug following each cycle of FLOT for 4 cycles.
Filgrastim or Pegfilgrastim is required on the study and should be administered per the package insert of the commercially obtained drug following each cycle of FLOT for 4 cycles.
Following 4 cycles of preoperative FLOT with RP2 injections, surgical resection of esophageal, GEJ, or gastric primary tumor per standard of care practice.
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